Novartis says "deep regret" over Japan drug trials scandal

TOKYO, Sept 26 | By Sophie Knight

TOKYO, Sept 26 The pharmaceutical head at Swiss
firm Novartis AG apologised to the Japanese public for
alleged manipulation of data in trials of its best-selling blood
pressure drug Diovan, saying an employee had acted
inappropriately.

Divisional head David Epstein made the comments after
meeting with Japanese health minister Norihisa Tamura in Tokyo.
He agreed to cooperate with the ministry to resolve the issue.

"We express our deep regret for the concern that the issue
has brought to patients, to the medical society as well as the
ministry," Epstein said.

"We are very willing to work with them and take additional
actions and potential sanctions in order to bring the issue to a
good conclusion," he added, but said he could not specify the
type of sanctions ahead of the release of the ministry's
findings at the end of this month.

Several Japanese hospitals have stopped offering Diovan
after two universities retracted papers printed in foreign
medical journals on the drug's efficacy for preventing strokes
and heart disease. The other three universities that published
research on Diovan are still investigating the matter.

Epstein said that a former Novartis employee who assisted in
all five trials had acted "way beyond what we consider
appropriate" and that the company had responded by strengthening
its training and oversight procedures at Novartis Pharma, its
Japanese arm, under new head Yoshiyasu Ninomiya.

Japan is an important market for Novartis, accounting for
around a quarter of Diovan's global sales before the scandal.
Novartis Pharma declined to disclose the impact on sales of the
drug, whose patent is due to end in Japan later this year,
allowing competition from generic copycats.

Novartis says the drug is effective for reducing blood
pressure and says patients should consult their doctors before
they stop taking it.
(Editing by Ben Hirschler)